Pf rounds up some of the most remarkable treatments to emerge in recent years.
Disarming cancer’s ‘invisibility cloak’
Developed by: Roche
Used to treat: Bladder cancer
Atezolizumab is an investigational monoclonal antibody cancer immunotherapy available in the UK via clinical trials and the first immunotherapy to go through the Early Access to Medicines Scheme for suitable patients with advanced urothelial (bladder) cancers. This PD-L1 inhibitor and works by disarming the cancer of its ‘invisibility cloak’, which allows the immune system – the body’s most effective medicine – to detect and destroy the tumour.
Andrew Ackrill, Principal PD Clinical Development Scientist at Roche Products Ltd, says that it has huge potential in the treatment of cancers: “It’s a very interesting drug.”
Atezolizumab is also being trialled as a treatment for a range of other cancers, alone and in combination, including colorectal (bowel) cancer, breast cancer, renal cell carcinoma (kidney cancer), small cell lung cancer, other solid tumours, diffuse large B-cell lymphoma and paediatric cancers.
“Combining targets gives a synergistic approach,” says Andrew. “It’s a very hot area. We’re very much at the beginning of an exciting time.” Before now, there had been no significant advances in the development of treatments for bladder cancer for 30 years.
Andrew says that it is thanks to Roche’s commitment to oncology, along with the opportunity to share knowledge and expertise with 21 leading centres around the world through Immunocore, a world-leading biotechnology company focused on the development of this new class of immunotherapeutic drugs, that the current advances are being made. “Roche has a proud history in oncology and I’ve never seen this level of engagement and activity. It’s very special.”
Andrew and his team of researchers at Roche have seen complete responses to atezolizumab, but only time will tell if the effects will endure in these patients, who are still being followed. “The durability comes with time,” he explains. “In immunotherapy we’re looking at improved response rates – the ultimate goal is to extend the lives of people. Survival is the ultimate goal.”
Cure for a chronic condition?
Developed by: MSD
Used to treat: Chronic hepatitis C virus
Hepatitis C virus (HCV) is a blood-borne virus that predominantly infects the cells of the liver. There are an estimated 150 million people worldwide chronically infected with HCV, which can cause inflammation and significant damage to the liver. Recent research shows that HCV can also affect the digestive system, lymphatic system, immune system and brain.*
For 30 years, MSD has been at the forefront of the response to the chronic HCV epidemic. The licensing of elbasvir/grazoprevir marks the latest innovation in the company’s longstanding investment in finding treatments for chronic HCV infection.
In 1991, MSD’s alfa interferon became one of the earliest licensed treatments for chronic HCV. 20 years later, its HCV protease inhibitor became one of the first direct-acting antiviral medicines against chronic HCV in the EU.
With the licensing of elbasvir/grazoprevir in July 2016, MSD introduced a new cure for many patients with genotype 1 (GT1) or genotype 4 (GT4) chronic HCV.
Cendrine Banerjee-Quetel, Associate Director, Policy & Communications, External Affairs, MSD, said: “The clinical development program for elbasvir/grazoprevir was designed to investigate this combination across diverse HCV patient populations, including those with severe renal impairment, on opioid substitution therapy, patients with compensated cirrhosis, or with HCV/HIV-1 co-infection.”
The licensing of elbasvir/grazoprevir was supported by eight clinical trials in approximately 2000 patients. The combination, with or without ribarvirin, is approved for the treatment of chronic HCV in adults with genotype 1 and 4 infection.
MSD is not resting on its laurels, however, and work on HCV carries on: “MSD continues to conduct clinical development work in hepatitis C, across a range of agents and types of patients,” enthused Cendrine. She adds that patients – aware of the consequences of long-term HCV infection – “are relieved at the opportunity of a cure”. *hepctrust.org.uk
A Nobel Prize-winning active ingredient
Medicine: Soolantra 1% ivermectin cream
Developed by: Galderma
Used to treat: Rosacea
Ivermectin, the active ingredient in Soolantra cream, is derived from a single micro-organism found in Japanese soil. It is an antiparasitic, which is also used to treat other conditions, including head lice, scabies and river blindness. In 2015, the scientists who developed ivermectin – William C. Campbell and Satoshi Omura – won a Nobel Prize for the research that led to developing the drug, which has reduced transmission of parasitic tropical diseases.
Commenting on ivermectin, Dr Emma Wedgeworth, Consultant Dermatologist & British Skin Foundation spokesperson, said: “Topical ivermectin has been a very useful addition to the armamentarium of topical treatments in rosacea. It has shown to be effective in the treatment of papulopustular rosacea, and superior to some conventional therapies.”
She added that the precise action of ivermectin is unknown: “It’s unclear how much of ivermectin’s antiparasitic activity is responsible for its effect in rosacea. A small commensal mite known as demodex has long been associated with rosacea, but a causal link has not been proven. Topical ivermectin also has anti-inflammatory effects by decreasing cellular and humoral immune responses. Inflammatory pathways play a pivotal role in the aetiology of rosacea.”
What the experts do know is that however ivermectin works, it is a welcome relief for the sufferers of this distressing condition. “It may be that a combination of its antidemodex and anti-inflammatory effects lead to its efficacy in rosacea,” concluded Dr Wedgeworth.
A contraceptive for the 21st Century
Medicine: Sayana Press (medroxyprogesterone acetate)
Developed by: Pfizer
Used to: Enable women to self–administer contraception
Sayana Press is a revolutionary self-administered Long-Acting Reversible Contraceptive (LARC) injection, which gives women 13 weeks of effective contraception with no need for daily dosing.
According to Dr Diana Mansour – Consultant in Community Gynaecology and Reproductive Healthcare, New Croft Centre – Sayana Press helps women to stay in control of their contraceptive choices, which is what they want from their contraceptive in the 21st century: “Ideally they want a method that is highly effective, reversible, with non-contraceptive benefits and under their control. Sayana Press, containing 104 mg medroxyprogesterone acetate in a pre-filled, simple injection system, fits the bill.”
Following the commencement of Sayana Press, no pregnancies were reported in two open-label, phase III clinical studies at one year, across 16,023 women-cycles of exposure. Its efficacy was not affected by weight, meaning that no dose adjustment is needed for women who are overweight or obese. Normal fertility also returns within 12 months of discontinuing the contraceptive injection.
Sayana Press doesn’t only protect women against pregnancy, it also has other benefits. “One of the best loved non-contraceptive benefits with progestogen-only injectables is the high rate of amenorrhoea (the absence of periods),” said Dr Mansour. “Over 50% of women using Sayana Press report no periods at the end of the first year. Reducing menstrual bleeding also means a reduction in period pain.”
Another benefit of this contraceptive is that it is licensed to be self-administered by women. “In the past, women needed to visit their GP surgery or sexual health clinic every 12 to 13 weeks to receive their injection,” reflected Dr Mansour. “Now at their first or second consultation they are able to give their own injection, and when confident, be prescribed up to a year’s supply of Sayana Press to self-administer at home.”
This ease of use is backed up by the data. “Research has shown that self-administration of Sayana Press is ‘easy’ and acceptable with approximately 50% of current users of injectable contraceptives interested in trying this new approach. There is also the potential to increase treatment compliance over time with self-administration,” Dr Mansour explained.
Self-administration of Sayana Press also saves the NHS money, reducing clinic attendances for women and allowing more time for other consultations in the GP practice or community contraceptive clinic. “It has been estimated that self-administration could save the NHS £38.92 per patient each year, if seen in primary care,” Dr Mansour added.